Category Archives: Spotlight Interviews

Stacey Willard, PhD, Senior Research Scientist, Eppendorf

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Stacey Willard, PhD

Dr. Stacey Willard earned her PhD from the University of Virginia. Ever since, her research was focused on biopharmaceutical development. Stacey has almost 20 years of experience in drug development and held positions in academic institutions (Johns Hopkins School of Medicine, the Roswell Park Cancer Institute) and within the biopharmaceutical industry. Since 2013, Stacey has been a Senior Research Scientist at Eppendorf, Inc.

What do you enjoy most about presenting on live webinars?

I enjoy the feedback from participants.

What are you looking forward to discussing with the audience?

Our work with the BioFlo 320 was very rewarding because we were able to really showcase the flexibility of the control station and were able to achieve some really nice titres in cell number and productivity. I love sharing those types of experiments!

Where is your favourite place in the world and why?

I recently had the pleasure of visiting some customers in Asia and I think my visit to the beach at Nha Trang, Vietnam just edged out my former favourite of Paris!

In your webinar you will be focussing on optimizing the biosimilar production process, discussing experimental results from a collaboration between yourselves and TPG Biologics. Why is this an important topic for the audience?

Biosimilar process development is a hot topic right now – there are quite a few blockbuster drugs that are going off patent in the coming years and the opportunity is there for the taking. There has been so much discussion in the industry on validating the potential biosimilar, but not as much talk on the beginning stages.

Once you have a cell line that produces a potential biosimilar, you must decide what experimental protocol to use, it must be easily scalable, it must be flexible, and it must make high levels of product at reasonable cost. This is where our work fits in. Often, trying new process protocols leads to large equipment purchases and controller changes. At the R&D or process development scale, we can provide the flexibility that the field is looking for. I’m excited to share that with the audience.

How did you get into the industry?

My background is in Genetics and Cell Biology. I have grown established cell lines of all types and have established my own cell strains from primary source tissues. Relying on that instinct and experience in cultivating cells, bioprocess was a logical next step for me. I know what cells need, and the bioprocess control platform allows me to achieve those parameters and to make the necessary tweaks during an experiment to get happier healthier cellular machines. It is very gratifying to be able to use the breadth of my training in process development and optimization.

Join Stacey and Eppendorf as she discusses Optimizing a Biosimilar Production Process!

Guy Matthews, Market Development Manger, Parker domnick hunter

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Guy Matthews has worked in the biopharm industry for the last 20 years starting his career as a Scientist at a well-known CMO in the UK before moving to more commercial roles. During this time he has been involved in many projects implementing single-use technology in both upstream and downstream bioprocessing.

Guy Matthews

Guy now works as Market Development Manager (Life Sciences) for Parker domnick hunter where he is focused on bringing Parker’s expertise in motion and control to bioprocessing, to create robust solutions in single-use technology to enable customers to improve the quality and accessibility of biopharmaceuticals.

 

 

What do you enjoy most about presenting on live webinars? 

In an age of blogs and tweets it is great to have an opportunity to engage and discuss with the wider bioprocessing community on a subject in detail. With in a webinar we have the opportunity to expand on a few the issues, with out feeling the need to artificially compact the message.

What motivates you?

What motivates me is that I passionately believe in single-use bioprocessing. I believe there are life saving products on the market today that would not but for the fact that they can be made in single-use systems. So the more robust we can make single-use the more they will be implemented resulting in better access to these life changing medicines.

What do you most enjoy about your role?

I have always enjoyed working with a customer to solve a particular issue. I also enjoy the challenge of working with the team to create a solution that enables our customers to do more. We are fortunate enough to be working in an industry that is evolving fast so trying to look to the future to be ready for those challenges is also exciting

What are you looking forward to discussing with the audience?

As I said I passionately believe in single-use technology, but see some of the challenges that still exist. One of those is the need for standardization so I am looking forward to discussing how we can keep the advantages of customized single use solutions but at the same time bring the advantages standardization to the process. With standardization should come higher quality, shorter lead times, a more robust supply chain and lower costs.

What do you hope the audience will learn from this webinar?

I hope to share some ideas and have a discussion on what areas we should be looking for standardization, how some level of standardization could be achieved and what benefits that may bring. I will be doing this by looking at some ideas we may be able to adapt from other industries as well as discussing my thoughts. I would hope the audience would learn that standardization is possible while still having all the benefits of a custom single-use solution.

Join Guy and Parker domnick hunter for their webinar as they discuss Single-Use Design.

Myriam Delvaux, Global Pharma Marketing Leader, Dow Corning Healthcare Solutions

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Myriam DelvauxMyriam Delvaux is in charge of developing and implementing the Global Strategy for the Pharmaceutical segment of Dow Corning; she also is managing the global portfolio of innovation from front end to commercialization.

Myriam’s career with Dow Corning spans more than 19 years during which time she gained global experience in a variety of marketing roles. These have given her a deep insight into strategic business to business marketing and business development.

Prior to being appointed to her current position, Myriam was responsible for acceleration of innovation platforms serving several industries; in that role she developed strong skills to bridge Mega trends with technology platforms. Earlier in her career she led the global market strategy serving the skin care market aligned to the Beauty Care industry. Myriam joined Dow Corning in 1996 after working for the Colgate Palmolive European Technology Center managing Global initiatives for Personal care, all-purpose cleaners and dish liquids categories. She led the launch of the first liquid for machine dishwashers.

Myriam earned a bachelor’s degree in Physical Sciences, specialization in Nuclear Sciences, from Louvain-la-Neuve University, Belgium.

1. How did you get into the industry? What are the top challenges faced by the pharmaceutical sector at this moment? How does your company deal with these challenges and how do you anticipate in your role? 

My career with Dow Corning spans more than 19 years during which time I gained global experience in a variety of marketing roles. These have given me a deep insight into strategic business to business marketing and business development.  The Healthcare industry, and specifically the pharmaceutical sector, is very challenging and extremely fascinating.

Our role is to create the business conditions to encourage innovation across the whole process from drug discovery through to market approval . Acceptance is one of the key challenge today: increasing collaboration across the entire spectrum of each interaction would greatly contribute towards bringing safe and efficient medication to the patient.

2. What motivates you?

The challenges you face in this industry are very complex and exciting! In this highly regulated market, it is becoming more and more challenging to enable innovation via new technologies in an affordable and timely manner. From contacts with regulators to payers, to pharmaceutical companies, to other  suppliers,  collaboration is key and can accelerate the entire process of bringing innovative treatments safely to market.

In which other industry are you so close to Health and Wellness? Each morning , you know that your role can improve patient’s quality of life across the globe!

3. What do you most enjoy about your role?

Being able to contribute to patient compliance and product efficiency. You can change lives, impact families the way only professionals in the healthcare can do providing efficient  solutions in a variety of forms that helps treat diseases.

4. What are you most looking forward to sharing with the audience?

This webinar will guide formulators in Pharma & Consumer Healthcare  companies together with laboratory staff, project managers, scientists, regulators through today’s healthcare market situation and its challenges .

We will showcase solutions  helping  to increase delivery efficiency together with offering enhanced aesthetics that could improve patient compliance We will also explain that it is key to select the right excipient(s) from the beginning with the appropriate regulatory package to support pharmaceutical or consumer applications and filings.

5. What do you hope the audience will learn from this webinar?

That silicone materials have a use history of more than 60 years in health care applications because of their wide biocompatibility profile, superior bio-durability, and outstanding versatility. Dow Corning is a trusted and experienced partner that provides its expertise to the benefits of his customers.

We hope that the audience will learn about the benefits of silicone-based material in topical applications, how to formulate effective topical formulations with silicone-based materials, how to make sure your ingredients and excipients are regulatory compliant, and especially how we can help accelerate the development of consumer healthcare topical solutions.

Join Myriam and other speakers from Dow Corning in their upcoming webinar as they discuss Effective Silicone-based Topical Formulation!

Tim Moran, Director Life Science Research Product Management, BIOVIA

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Tim MoranTim’s early research in the industry focused on Immunomodulation and Imaging to study of effects on T-cell lymphocyte homing. He held several managerial positions in Image Informatics and came to the organization in 2006 to begin work as Director of Image Informatcs. His role has expanded over the years to include Life Science Research Marketing and Product Management for Assay Management, Next Generation Sequencing, Sequence Analysis, Biotherapeutics, and Bio Registration.

1. What are you looking forward to discussing with the audience?

So many pharmaceutical and biopharmaceutical organizations are increasing their focus on biotherapeutic drug development in order to remain competitive in the market. Unfortunately, this can backfire when these organizations don’t take in to account the resources required for managing the additional complex data and processes involved. This can increase exposure to compliance risk, decrease overall productivity and extend the time to market for new products. I’m excited to have the opportunity to show the audience that there is a better way to not only manage, but leverage biologics data by eliminating inefficient paper-based workflows, reducing the effort for creating experiments, providing better understanding of processes and products, and much more.

2. You’ve mentioned that the biologics discovery workflow is similar to small molecule discovery at the highest level but that there are differences in the details. Can you explain what changes as an organization shifts toward biotherapeutic development?

In short, biologic discovery demands unique processes due to the added complexity of biological systems. Compared to small molecule discovery, biologics workflows generate a large amount and a large variety of complex data. However, being able to distill the information and track the genealogy of how to get to an end entity is critical. This requires some advanced data and workflow management.

3.  Why do you feel this topic is important?

In a recent market survey conducted by industry analysts IDC, it was shown that just 6 of the top-selling drugs in 2014 were biologics. In 2018 however, it’s estimated that over 50% of the top 100 prescription and OTC drug sales will be biologics. This clearly shows the strong industry trend shifting to biologics and with that industry shift, life science organizations will need a robust informatics solution to manage the increased complexity of biologics.

4. What do you hope the audience will learn from this webinar?

By attending this webinar, I hope the audience will see the true potential impact of transitioning from disjointed workflows and what has primarily been   a paper-based to an electronic Biologics solution covering all activities of the discovery process and how that positively affects their bottom line.

Join Tim in the BIOVIA webinar ‘Integrated, Predictive and Collaborative Workflows in Biologics Discovery‘. Register now!

Dan Matthews, CTO, IFS

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As the Chief Technology Officer (CTO) at IFS, Dan’s responsibilities encompass researching, formulating, and communicating the strategic direction of IFS Applications. Dan leads the Research & Strategy unit, which includes IFS Labs. He also manages IFS’s technical partnerships with Microsoft, Oracle and other players. Dan is a frequent speaker at IFS and industry events.

Since joining IFS in 1996, Dan has held a number of positions within the company, including software engineer and project manager. In his IFS career, Dan has been the driving force behind major projects such as the development of the innovative IFS Enterprise Explorer user interface, the IFS Touch Apps, a series of cloud-based smartphone apps for the enterprise, and IFS’s move to the cloud.

Dan Matthews is a graduate from the Linköping Institute of Technology, where he studied computer software and software engineering. While still at university, Dan founded his own software development company, which he left to pursue a career at IFS.

Outside of the workplace, Dan pursues his hobbies of carpentry and cross-country skiing.

1. Why did you decide to do a webinar with Business Review Webinars?

This is our third time around I believe. We had quite a good turn out the first couple of times so continuing with a winning concept.

2. What is your favorite thing about presenting to a live audience?

Actually it is the opportunity to get and answer questions. Having this interaction, which you can only have with a live audience, makes it much more interesting for me, and I believe for the people listening in as well.

3. What are you looking forward to explaining to the audience?

What it means to take a pragmatic approach to the Internet of Things. There is so much hype around this topic that someone needs to look at the practicalities of going from talking about IoT to doing something and getting some benefit back.

4. Where is your favourite place in the world and why?

There has to be two answers to this. One place is home. That’s where I have my family and my own little piece of this world—the place I can just be. The second is Melbourne, Australia. It’s relaxed, small enough to get around on foot, fantastic climate.

5. What do you do in your leisure time to relax?

I build stuff. Mainly things like walls, stairs, sheds and things around the garden. Best thing so far was building a Swedish “lusthus” (yes, it means lust house). If you don’t know what they look like just google some pictures.

Join Dan, along with speakers from IDC an Microsoft as they discuss the ‘Top 3 Questions to Address When Planning for IoT‘. Register now!

Thomas Jydby Hedemark, Industry Segment Specialist F&B, Baumer Electric AG

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Thomas HedemarkThomas holds a degree of the Tietgen Skolen in International Business. In different management positions he gained extensive experience within the global food and beverage market.

Thomas has particular experience with process sensors used within the brewery and dairy segment.

1. How did you get into the industry?

When I started working as a field Sales Engineer in 2007, the customer base I inherited was mainly within this segment. Around 50% within dairy and brewery applications. My main task, at the time, was to develop our F&B business for process sensors and this was my entrance to the industry.

2. What do you most enjoy about your role?

Working within sales you naturally enjoy the social aspects of the job, for example working with customers on process optimization and general problem solving. But, also internal communication
with product management on campaigns and future product requirements.

3. What are you looking forward to explaining to the audience?

How they can benefit from using Baumer process sensors within the CIP process.

4. What’s your favourite thing about presenting to a live audience?

I don’t have much experience in presenting live webinars unfortunately. I’m really looking forward to the experience!

5. What one item would you take with you to a desert island?

If only one thing it would be music, closely followed by hammock and knife. But, who would go to a desert island in the first place?

Join Thomas for a discussion on ‘How to Ensure Food Safety While Increasing Overall Equipment Effectiveness‘ in our webinar with Baumer Electric AG. Register now!

Paul Daniel, Senior Regulatory Expert, VAISALA

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Paul Daniel, Senior Regulatory Expert at Vaisala, has over 19 years of validation experience in the pharmaceutical and medical device industries.

Paul has worked on a wide range of qualification projects, including process, cleaning, shipping, laboratory equipment, packaging, software, network, and computer validation, and extensive practical grounding in applying the good manufacturing practices principles of the FDA 21 CFR Parts 11, 210, 211, and 820.

An expert in authoring and executing validation protocols for pharmaceutical manufacturing and software validation with a risk-based approach drawn from GAMP guidelines. Paul holds a bachelor’s degree in biology (with honors) from the University of California, Berkeley.

What is your favourite thing about presenting on webinars?

It is an opportunity for me to give something back to the professional Life Science community which has given me a rewarding career in Validation.

What are you looking forward to explaining to the audience?

Mean Kinetic Temperature (MKT) is a really interesting topic. There is a deep and engaging story in the history of MKT that is intertwined with the history of HVAC and monitoring technology, and heavily influenced by ongoing regulatory changes in Good Distribution Practice. I am looking forward to sharing this story, so that we can see how our understanding and use of MKT has changed over the last 40 years, and hopefully, have a better idea of where this unique tool can be used effectively today.

What attracted you to the industry and what do you enjoy most about working at VAISALA?

I became involved in Pharmaceutical Validation because I was good with details, and I was seeking an industry where my work would have a direct link to improving quality of life. I joined Vaisala over 4 years ago because I thought it would allow me to be more effective at influencing positive change within my industry. I really like Vaisala because this company is dedicated to making the world a better place, one measurement at a time. Our mission statement – Observations for a Better World – conveys this idea. And, I really enjoy working with excellent people, in an established international company, that continues to create technology that changes the world. I may work in the narrow niche of Temperature Monitoring for Pharmaceuticals and Medical Devices, but Vaisala is involved in a much wider scope of enterprise that includes weather, road safety, interplanetary exploration, and preserving cultural treasures. I can’t imagine a more exciting place to work!

What is your favourite holiday destination?

I don’t have a favourite. But if you gave me two-weeks off and an expense account, there are a few places you would likely find me; high in the Colorado mountains fly-fishing an isolated stream, riding a mountain bike on remote single-track trails in the Pyrenees, or asleep in the sun on a beach in Mexico.

How did you spend the Easter holiday?

Easter was spent with friends and family, enjoying the return of spring, sitting in the sun, and talking about our hopes for the coming year.

Join Vaisala’s webinar with Paul on “Mean Kinetic Temperature in GxP Environments”. Register here.

Tom Homer, Managing Director, EMEA, Telstra

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Tom HomerWe recently caught up with Tom Homer ahead of the Telstra webinar ‘Connecting Companies: Strategic Partnerships for the Digital Age‘ to find out a little more about him. Find out what he had to say below.

Tell us about your company and your areas of expertise?

Telstra is a leading telecommunications and technology company. We have been operating successfully on an international level for more than 70 years, having built a world class network and established customer relationships and partnerships with some of the most innovative companies around the world. In the UK and Europe our focus is on the large enterprise market where we provide a range of solutions including managed network services, global connectivity and cloud.

As is often said in tech circles, software is eating the world, and it certainly is creating opportunities for Telstra to better serve our customers. We have started offering what is called Software Defined Networking and Network Functions Virtualisation on our network across our global Points of Presence, which makes it easier for customers to provision the services they need quickly and in a simple way.

Beyond traditional telecommunications services we are also developing our business in new areas such as software, e-Health and monetization of video streaming.
Tell us about your IT career?

I’ve been working in IT for the past twenty five years, having begun my career at AT&T before moving to Energis, the fourth largest telecommunications company in the UK at the time.

It was during my time at Energis that the concept of cloud and its potential to unlock real business value was gaining popularity, and one of my favourite projects was working with Boots to launch their foray into online digital photo sharing.

I joined Telstra in 2011 and was tasked with spearheading our growth in the UK and into new territories. Based in London, today I’m responsible for developing and driving the business strategy across Europe, the Middle East and Africa along with growing our relationship with multinational corporations across the region.

What tech do you expect to be involved with in ten years’ time?

In my view, there is no doubt that software will continue to dominate the IT industry over the next ten years, in particular the rise of software defined networking (SDN).

Businesses are facing ever increasing demands on network bandwidth, which is being driven largely by the evolution of modern, dispersed and collaborative workplaces, often with the need to transport rich content and communicate through new digital channels.

Business leaders are adopting “anywhere, anytime” flexible workforces, with an appetite for cloud service adoption and application consumption. This consumption, coupled with technologies available to collect valuable business insights, is producing huge quantities of data that is growing exponentially and must be delivered quickly, securely and efficiently.

I believe success in the next decade lies in high capacity and low latency SDN solutions, which can seamlessly allocate network resources based on individual requirements. With this level of intelligence, network providers can demonstrate cloud like characteristics such as self-service, on-demand and scalability through a unified delivery infrastructure.

What is the greatest challenge for an IT company or department today?

Until recently, the main challenges facing IT departments were selecting the right hardware and software, deploying them quickly at minimal cost and keeping them working. However, a new challenge is edging its way up IT executives’ list of concerns. Many employees are deciding for themselves what IT they need and are proceeding to use it in the workplace without corporate approval.

The risks related to this growing trend – termed Shadow IT – are huge. Because the IT department has not extended its security policies and technical solutions to the unauthorised technology, the company’s IT environment and data may become considerably more vulnerable.

How should IT departments deal with the emergence of shadow IT? The answer is to start listening to individuals and teams throughout the business to help ensure employees have access to the latest collaboration tools they want, empowering them to do their jobs more effectively.

Who is your tech hero (and why)?

It’s a bit cliché but my tech hero would have to be Steve Jobs. There’s a great quote in Eric Schmidt and Jonathan Rosenberg’s book, “How Google Works”, where they describe Jobs as the quintessential “smart creative” – an expression for someone with a combination of technical depth and creative talent.

His vision extended far beyond just creating technology to make money, which is evidenced today in the profound impact Apple technology has had on the world, helping transform everything from the way children learn to how we can monitor and improve our health.

Want to hear more? Register for the Telstra webinar to discover how your company can benefit from a strategic partnership. Register now!

Cyril Walsh, BIOVIA Sr. Solutions Consultant, BIOVIA

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Cyril WalshCyril has extensive knowledge on the management of Quality and Regulatory affairs pertaining to automated content management. Cyril has implemented Quality based processes for the management of CAPAs, Deviations, Change Control and Complaint handling. Cyril also has in-depth experience in the services arena having previously worked for Accenture, before beginning his 13 year tenure at QUMAS, now part of BIOVIA, the leader in quality and compliance management solutions for the Life Science industry.

1. What are you looking forward to discussing with the audience?

The focus of our discussion will be defining a true Total Quality strategy and why it’s so critical for Life Science companies. We will give an overview of the challenges of implementing a solution for Total Quality as well as how to overcome them,  the required capabilities for  a Total Quality solution that spans the entire scientific product life cycle from ideation to commercialization and the benefits an organization will experience when implementing a Total Quality strategy.

2. You’ve mentioned that a Total Quality approach includes Quality Process Management, Quality Control and Testing, Materials Quality Management, Quality Document Management and Quality and Process Data Analytics. How would you implement these?

We definitely advise taking a phased approach for the implementation of a Total Quality strategy. Depending on the specific situation and the existing landscape of supporting systems the focus of the first stage can vary. While some of the areas are independent a QMS (Quality Management System) can be a good basis to go forward playing into all stages of the product lifecycle. Usually it is the core of the Total Quality strategy. And as consistent and traceable documentation is basic we recommend considering implementing a centralized integrated system for QMS and Document Management .But we should not forget that metrics are required to validate Quality and in Life Sciences consistent Quality Control procedures and processes are indispensable.

3. Is this topic only relevant for roles that are directly engaged in working with Quality?

Many capabilities play into the successful management and execution of Quality. This includes for example, the definition, documentation, submission, monitoring and management of quality related activities and tasks as well as the execution of quality tests. The BIOVIA approach will support the FDA mandate for deeper integration of Quality into end-to-end operations to design quality into products and processes as well as foster a quality culture across all areas of an organization from discovery to commercialization.

4. What do you hope the audience will learn from this webinar?

By attending this webinar, I hope the audience will which are the relevant aspects and capabilities and the true potential impact of a comprehensive Total Quality Strategy throughout the entire product lifecycle.

Join Cyril in the BIOVIA webinar ‘Bringing Your Total Quality Strategy to the Next Level‘. Register now!

Steven Jiroutek, Business Development Manager, VAISALA

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Steven Jirsteveeeeoutek is the Business Development Manager for Industrial Applications at Vaisala, Americas. With over 12 years of experience at Vaisala, he oversees the business and strategy development for targeted industrial applications with specific focus on condition based monitoring of high voltage assets. He is responsible for identifying strategic partnerships and defining the measurement, technology and product needs of the markets. Steve holds a Bachelor of Science degree in Chemical Engineering from the University of New Hampshire.

 

  1. Why did you decide to do a webinar with Business Review Webinars?

Vaisala has always been an innovation and technology driven company with a strong customer focus.  We work closely with many pilot customers in order to help us bring new products to market.  In this process we discover new insights and best practices and are always looking for new ways to share our latest findings with other industry experts.

  1. What are you looking forward to explaining to the audience?

The concept of moisture movement within transformers is pretty well known in the industry however what’s less understood are the finer points related to how it happens, what it means, and how it’s measured.  I really enjoy taking a complex, confusing topic and helping to bring clarity to it by presenting new ideas and perspectives to a diverse audience.

  1. How did you get into the industry and what do you most enjoy about your role?

My background in chemical engineering served me well in understanding gas and liquid measurement applications however I knew from a very early point in my career that the “traditional engineer” role wasn’t going to suit me.  I moved pretty quickly to being on the front lines of business development and engaging with market leaders about new technologies & trends and applying that information to product development – this was a much better fit for my personality and interests.

  1. What are you hoping to achieve in the future in your personal and professional life?

The most important thing for me now and in the future is to always maintain the proper balance of time with my family and work that is meaningful and challenging to me.

  1. How do you relax in your leisure time?

The best way for me to recharge my batteries is to be active in nature – I’m an avid skier, hiker, backpacker, runner, and mountain biker.

Join Vaisala’s webinar with Steven on “Moisture in Transformer Oil Behavior” . Register here.